Robert S. Jacobson and Kate Nuehring Su, associates at Marshall, Gerstein & Borun discuss key IP considerations for patenting 3D printed medical supplies and devices and how the COVID-19 pandemic could shape innovations over the next few years.
Innovators have sought to address the urgent challenges and supply shortages created by the COVID-19 pandemic by harnessing 3D printing technologies to develop and improve various medical devices. For example, when supply chain problems caused a critical shortage of nasal swabs, a team at the University of South Florida (USF) developed a 3D printed swab that uses nubs instead of a traditional polyester flocked head to collect tissue. The team provided the files to hospitals and healthcare systems worldwide, and over 70 million swabs using their design have been printed. What might be surprising is that, in addition to freely distributing the files for their swab design, the USF team also filed a provisional patent application.
Patents are valuable tools that let manufacturers of 3D printed medical supplies and devices protect their innovations from being made, sold, or used by others. To obtain a patent, the innovation must at least be novel and non-obvious. “Obvious” is not understood in the colloquial sense; rather, obvious is a legal term that involves a rigorous analysis. In 3D printing, this may mean that simply replacing a conventionally manufactured part with a 3D printed equivalent is not sufficient to obtain a patent. Instead, one should focus on the particular differences between conventional parts and 3D printed parts.
For example, does the 3D printed part (e.g., the USF nasal swab) have a more detailed geometry than a conventionally manufactured part? Does the 3D printing process allow for multiple parts to be integrated into a single 3D printed part? Is there a unique way of printing the part as compared to other 3D printed parts? These are among the considerations that are important in assessing whether an innovation is best protected via patents.
Another important consideration is understanding the specific protection afforded by a patent. Take, for example, a patent for a physical dental implant that is printed based upon a scan of a patient. Now imagine that a competitor was to scan the patient and send the patient a CAD file for printing at home or via a 3D printing service. The company that scanned the patient and sold the CAD file did not make, sell, or use the physical dental implant. Accordingly, the patent owner may have to rely on more complicated doctrines of indirect infringement or seek damages from the patient. As such, it is important to ensure that the patent protection is crafted such that the business model surrounding the innovation is also protected.
The patent system is intended to reward the effort put into innovation but asserting a patent on a necessary technology amid a global pandemic runs counter to the very purpose driving many inventors: to help those in need. To balance these competing priorities, an international group of researchers, scientists, academics, and lawyers developed the Open COVID Pledge. The Open COVID Pledge involves making one’s intellectual property free of charge for use in ending the COVID-19 pandemic. By making the Open COVID Pledge, an IP owner grants everyone a royalty-free license to make, use, sell, or import the pledged patent for the purpose of diagnosing, preventing, containing, and treating COVID-19. The Open COVID licenses last until one year after the World Health Organisation declared the COVID-19 pandemic to have ended but, in any event, not beyond January 1, 2023.
In that time, some of the pledged 3D printing technology that might be freely commercialised includes:
- 3D Printed Customised Medication: IBM pledged U.S. Pat. Pub. No. 2021/0008869A1, which is directed to a method for printing customised 3D medication using a patient’s medical records.
- 3D Printing of Biologically Derived Materials: NASA pledged U.S. Pat. No. 10,815,474B1, which “combines 3D printing technology with artificially modified cells for production of nonliving biomaterials.”
- 3D Printed Model for Surgical Planning: IBM also pledged U.S. Pat. Pub. No. 2020/0015893A1, which describes a method for making a three-dimensional model of a patient’s organ for purposes of pre-surgical planning.
While there is uncertainty and legal risks in how it will play out, the Open COVID Pledge is an encouraging example of how companies are able to work together to mitigate legal hurdles that would otherwise hinder collaborative solutions to global problems. The lessons learned in setting up the legal framework to fight COVID-19 in a decentralised manner will provide the medical device industry confidence that open and collaborative approaches are viable and that new sources of innovation are possible.
